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Product sales increase during unprofitable year for CytogenFDA announces MQSA enforcement actions

The director of the FDA’s Office of Device Evaluation has informed iCAD that the agency will approve its SecondLook Digital computer-aided detection software for use on Fujifilm’s computed radiography mammography system (CRm), according to Ken Ferry, president and CEO of the company. iCAD has spent 20 months seeking FDA approval for the software.

Computer-aided detection may lend an extra punch to the diagnosis of pulmonary embolism with multislice and dual-energy CT scanners. Studies by French and German researchers have shown it helps detect small, hard-to-spot clots lodged in the lungs’ periphery.

Computer-aided detection and diagnosis tools were showcased at Saturday’s “ESR meets Germany” session. Speakers highlighted four key clinical areas where advances could make a real difference to diagnostic decision making.

Cutting-edge pathology techniques will demonstrate the true nature of breast cancer during the opening session of a categorical course Friday afternoon. Rare and potentially revolutionary, the new methods look set to challenge radiologists’ understanding of breast cancer and could alter their approach to imaging interpretation.

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Quarterly losses balloon at MergeFuji targets mobile mammo marketSiemens allies with software firmNucletron unveils brachytherapy accessoriesMedQuist upgrades speech recognitionART lands first customerKonica wins sole-source contract Emageon taps new CFO

Studies of chest pain patients with conventional 64-slice and dual-source CT add to a growing base of evidence suggesting that CT is well suited to rule out acute coronary syndrome in the emergency room and to identify coronary artery in-stent restenosis.

A new study based on nearly a quarter million mammograms suggests screening mammography with computer-aided detection is more sensitive than double reads. The findings contradict a key study published last year questioning its effectiveness.

Philips Medical Systems has been noticeably absent in digital mammography, at least in the U.S. This could change as early as the second half of 2008 if the FDA approves the computed radiography component of a novel mammography system in development at the Dutch company, a vendor of virtually every other advanced imaging technology.

Business Briefs

Zonare ultrasound heads around the worldCarestream single-cassette CRs take holdFDA clears digital mammo workstationViewRay lands $25M

Israeli and U.S. researchers have found that computer aided-detection systems can boost the accuracy of chest radiography for lung cancer, especially when the procedures are performed by inexperienced readers.

Digital tomosynthesis detects more breast masses, better categorizes those masses, and produces lower callback rates than conventional mammography. In a study of symptomatic patients, tomosynthesis was not superior to mammography, but a combination of the two techniques detected more carcinomas than either alone.

Emory University trial results showed that a new technique called stereoscopic digital mammography reduces false positives by 49% and false negatives by 40% in women with an elevated risk of breast cancer. But the technique may have difficulty catching on, as it requires double the images and double the radiation dose compared with conventional digital mammography.

While demand for MR and CT equipment languishes, digital mammography is enjoying a heyday with no end in sight. When the final numbers are tallied, vendors expect to have shipped twice as many full-field digital mammography units in 2007 to customers in the U.S. as in the previous year. And 2009 could be more of the same.

A large prospective screening trial from the University of Pennsylvania compared screen-film mammography, digital mammography, whole-breast ultrasound, and contrast-enhanced MRI in a population of 569 asymptomatic women. In this single-center trial, funded by the National Cancer Institute, the definition of high risk included women with a 25% lifetime risk based on genetic testing or Gail or Claus models and those with a history of cancer in the contralateral breast.

Philips Medical Systems plans to be on the U.S. market with a computed radiography system for mammography in the second half of 2008 and with a flat panel mammography system in the first half of 2009. When approved by the FDA, they will be available as part of a digital platform that can support CR and DR, the first such hybrid ever.

Not since the height of the CT slice wars have vendors said so much about products that were so far from market. They have been talking up breast tomosynthesis for years, adding details with each passing RSNA meeting, whetting the appetite of a marketplace enamored of digital imaging. Looming larger, year after year, until it can no longer be ignored is the question-spoken or unspoken-that begins with the word "when."

Breast tomosynthesis used in the screening setting detects more breast masses, better categorizes those masses, and produces lower callback rates than conventional mammography, according to research presented at the RSNA meeting. Tomosynthesis was not superior to mammography in one study of symptomatic patients, but a combination of the two techniques detected more carcinomas than either alone.